ORR was defined as the percentage of participants in the analysis set who had a BOR of CR or PR based on RECIST v. 1.0 for target lesions. Tumors were assessed using x-rays, magnetic resonance imaging (MRI), or computed tomography (CT) scans, or both, as appropriate. ORR was documented and confirmed by two measurements taken at least 4 weeks apart. CR was defined as the disappearance of all target lesions. PR defined as ≥ 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Best overall response was derived using the same hierarchy as used when determining the PFS status at Week 12. No adjustments were made for participants who started further anticancer therapy prior to disease progression. 95% CIs were calculated using the exact method of binomial distribution. ORR = CR + PR

CRB was defined as the percentage of participants with a BOR of CR or PR or SD as defined by RECIST, described previously. BOR was derived using the same hierarchy as used when determining the status at Week 12. No adjustments were made for participants who started further anticancer therapy prior to disease progression. 95% CIs were calculated using the exact method of binomial distribution. CRB = CR + PR + SD

Time to onset of response could be calculated only if a participant achieved an objective response (BOR of CR or PR as defined previously). Participants who never achieved CR or PR were not included in the Kaplan-Meier survival estimates for the time to onset of response by strata. Given the small number of participants with these responses and the large variation in time to onset of response between participants, no comparison could be made among the strata.

Duration of response could be calculated only if a participant achieved a BOR of CR or PR, as defined previously. For consistency with the formula used by the European Organization for Research and Treatment of Cancer (EORTC), the duration was derived as "day of event minus day of first documented CR or PR" (one was not added to the calculation). Participants who were alive without documented progression had their duration of response censored at the day of last follow-up for progression. Participants who never achieved CR or PR were not included in the Kaplan-Meier survival estimates for the duration of response by strata. No adjustment was made for participants who started further anticancer therapy prior to disease progression.

Participants still alive at the end of the study had their time to event censored at the day last known to be alive. Participants lost to follow-up were also censored at the date last known to be alive. 95% CIs for the percentage of participants still alive at the end of the study were presented as described for the primary endpoint, PFS at Week 12.

Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. TEAEs are defined as an adverse event (AE) that emerged during treatment, having been absent at baseline or: reemerged during treatment, having been present at pretreatment (baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. All AEs and SAEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. A participant was counted only once within a System Organ Class (SOC) and preferred term (PT), even if the participant experienced more than one TEAE with a specific SOC and PT. Participants were summarized by treatment group according to the worst CTCAE grade assigned for each PT. Treatment-related TEAEs included TEAEs that were considered by the investigator to be possibly or probably related to study drug or TEAEs with a missing relationship.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.

Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.